Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura (HERCULES)

Ablynx

Status and phase: Completed; Phase 3

Conditions: Acquired Thrombotic Thrombocytopenic Purpura

Treatments: Biological: Caplacizumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02553317

ALX0681-C301

2015-001098-42 (EudraCT Number)

Details and patient eligibility

About

The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
3. Required initiation of daily PE treatment and had received 1 PE treatment prior to randomization
4. Others as defined in the protocol

Exclusion criteria

1. Platelet count ≥100×10E9/L.
2. Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L
3. Known other causes of thrombocytopenia
4. Congenital TTP (known at the time of study entry).
5. Pregnancy or breast-feeding.
6. Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
7. Others as defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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145 participants in 2 patient groups, including a placebo group

Caplacizumab

Experimental group

Description:

Caplacizumab 10 mg once daily

Treatment:

Biological: Caplacizumab

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Biological: Placebo